Kornimate/medical-research-clean huggingface dataset:
hypo-pressive abdominal exercise on inspiratory muscle strength, diaphragm thickness and pain in chronic nonspecific low back pain

Conditions: Low Back Pain

Summary: the purpose of this study will be to assess the effects of an 8-week hypo-pressive abdominal exercise program on inspiratory muscle strength, diaphragm thickness, pressure pain threshold and disability in patients with non-specific chronic low back pain. a randomized clinical trial will be carried out. a total sample of 40 patients with non-specific chronic low back pain will be recruited and divided into 2 groups including an experimental group (n=20) which will receive an 8-week hypo-pressive abdominal exercise program and a control group (n=20) which will not receive any training program. inspiratory muscle strength, diaphragm thickness, pressure pain threshold and disability will be assessed.


Eligibility criteria:
inclusion criteria: * patients with chronic non-specific low back pain exclusion criteria: * congenital diseases * rheumatic or neuro-muscular diseases * respiratory conditions * surgery * pregnancy
acute effects of whole body blue light exposure on blood pressure

Conditions: Blue Light

Summary: ultraviolet light exposure was shown to be able to release nitric oxide from the skin into the blood stream and lead to an acute decrease in blood pressure and increase in vascular function. additionally, preliminary work indicates that uv free blue light also releases nitric oxide in the skin mediating similar effects as seen with ultraviolet light a(uva). it is the goal of the present experimental study to investigate the hemodynamic effects of whole body blue light exposure including blood pressure, endothelial function and vascular stiffness. therefore, healthy volunteers will be exposed to 30 minutes whole body blue light (453 nm wavelength) and the change in blood pressure and endothelial function (flow mediated dilation (fmd)), heart rate, forearm-blood flow, forearm vascular resistance central blood pressure and vascular stiffness ( pulse wave analysis by sphygmocor) will be measured. in this randomized controlled cross-over study, 20 healthy subjects aged 30 to 60 years will participate.


Eligibility criteria:
inclusion criteria: * healthy, male subjects * age between 30 and 60 years * signed patient informed consent exclusion criteria: * diabetes mellitus * acute inflammation (crp \>0.5mg/dl) * cardiac arrythmia * active cancer * renal failure * heart failure (nyha ii-iv) * arterial hypotension (systolic pressure \<100 mmhg) * treatment with antihypertensive drugs * dermatosis of the eyelid * porphyria or hypersensitivity to porphyrins * congenital or aсquired immune deficiency * genetic conditions that cause an increased sensitivity to light or an increased risk to dermatological cancer (such as xeroderma pigmentosum, cockayne syndrome, bloom syndrome) * previous intake or use of photosensitizing drugs, food or cosmetics (e.g. psychiatric medication, antibiotics, cardiovascular drugs, hormone, hypericum, bergamot orange) or use of perfumes

Keywords: blue light blood pressure vascular function endothelial function health volunteers
the experiences of professionals with refugee patients

Conditions: Emergencies; Health Personnel Attitude; Child Development; Qualitative

Summary: this study was conducted to examine the experiences and feelings of health professionals while providing care to refugee children and families in pediatric emergency service.


Eligibility criteria:
inclusion criteria: * health professionals who worked in the pediatric emergency department for at least 1 year were included. exclusion criteria: -
3d versus 2d laparoscopic total gastrectomy with splenic hilum lymph nodes dissection

Conditions: Splenic Hilum Lymph Nodes Dissection

Summary: the investigators will perform a prospective randomized comparison between 3d and 2d laparoscopic total gastrectomy with splenic hilum lymph nodes dissection.

a prospective randomized comparison of 3d and 2d laparoscopic surgery for advanced gastric cancer with spleen-preserving splenic hilum lymph nodes dissection will be performed, to evaluate the safety and feasibility for the extensive application of the novel 3d laparoscopic technique. the evaluation parameters are number of group no.10 lymph nodes harvested, perioperative clinical efficacy, postoperative life quality and 3-year survival and recurrence rates.

Eligibility criteria:
inclusion criteria: 1. primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy; 2. ct2-4an0-3m0 at preoperative evaluation according to ajcc cancer staging manual, 7th edition. 3. eastern cooperative oncology group (ecog): 0 or 1; 4. american society of anesthesiologists （asa） score: ⅰto ⅲ; 5. written informed consent. exclusion criteria: 1. pregnant or breast-feeding women; 2. severe mental disorder; 3. previous upper abdominal surgery (except laparoscopic cholecystectomy); 4. previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection; 5. enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging; 6. other malignant disease within the past 5 years; 7. previous neoadjuvant chemotherapy or radiotherapy; 8. contraindication to general anesthesia (severe cardiac and/or pulmonary disease); 9. emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.

Keywords: gastric cancer 3d 2d
a follow-up comparison of sensory discrimination in patients with low back pain

Conditions: Low Back Pain

Summary: to determine if there is any carry over difference with sensation training to the low back for patients with low back pain with the addition of a training at home. this will be looked at to see if there is a difference in pain or back / leg movement right after the training and in a few days after doing some exercises at home.

in a previous case series patients with chronic low back pain (lbp) who received tactile acuity training to their lower back in the absence of movement, experienced immediate positive changes in pain ratings and spinal movements. these changes, however, where only measured immediate post-intervention. this study aims to use a similar design of sensory discrimination for lbp, but will include a sensory discrimination home exercise program and compare groups at a follow-up visit for any difference between groups (48-96 hours) of the immediate changes. changes will be assessed for pain and back and leg movement.

Eligibility criteria:
inclusion criteria: * adults over the age of 18 * patients presenting at pt with a primary complaint of lbp * lbp being present for 3 months or more * fluent in english * willing to participate in the study * they also will need someone who can assist with a sensory discrimination hep. exclusion criteria: * under age 18 * not able to read/understand the english language * prisoners * no medical issues precluding physical therapy treatment (red flags) * if they had undergone spinal surgery * if they had any skin or medical condition preventing them from receiving tactile stimuli on the lower back or had specific movement-based precautions, i.e., no active spinal flexion. - patients presenting with leg pain only * patients with neurological deficit only in the lower extremity

Keywords: low back pain sensory tactile education
oxazyme in patients with hyperoxaluria

Conditions: Hyperoxaluria

Summary: hypothesis: oral administration of the oxalate metabolizing enzyme oxazyme (oc4) will degrade food-borne oxalate and hence prevent its absorption from the gastrointestinal tract. in addition, by reducing oxalate concentrations in the gastrointestinal fluid, oxalate secretion from blood to the intestinal tract may be increased. both effects would decrease blood levels of oxalate, and hence oxalate excretion in the urine.

oxazyme is an oxalate degrading compound that can potentially degrade food-borne oxalate and hence prevent its absorption from the gastrointestinal tract. we propose a 20-patient open-label trial pilot study of one month of oxazyme twice daily (1gm oxazyme sachet dissolved in 150 ml water) among adult subjects with a history of calcium oxalate nephrolithiasis. patients will be stratified into those with enteric hyperoxaluria after roux-en-y gastric bypass (rygb, n=10) and those with idiopathic hyperoxaluria (n=10). the patients will perform two, 24-hour, urine collections immediately before starting oxazyme and on the last two days of the treatment period.

Eligibility criteria:
inclusion criteria: * roux-en-y gastric bypass hyperoxaluric calcium oxalate (caox) stone subjects or idiopathic hyperoxaluric caox stone subjects * patients must have or had radio-opaque stones present on x-ray, or a history consistent with the passage of a stone or stone surgery or extracorporeal shock wave lithotripsy (eswl) in the last 5 years. * hyperoxaluria ox/cr ratio ≥36 mg/g * the patient must be able to provide written informed consent * patients must be able to urinate reliably into a collection vessel to measure urine volume. * patients may be taking drugs for the prevention of stone disease, including pyridoxine, thiazides, citrate supplements and allopurinol, as long as there have been no changes in these medications for at least 3 months exclusion criteria: * primary hyperoxaluria patients * use of oxadrop, oxabsorb, or other therapies affecting oxalate absorption from the gut, other than stable doses of calcium. * subjects who are pregnant. women of childbearing potential must have a negative pregnancy test prior to enrollment and must practice some form of birth control during the trial. * patients on an unstable dose of any other drugs for the prevention of stone disease (i.e., pyridoxine, citrate supplements. etc.). patients should have been on a stable dose for at least 3 months prior to randomization.

Keywords: hyperoxaluria oxazyme oxalate enteric hyperoxaluria
anxiety reduction in tavi using virtual reality trial

Conditions: Aortic Stenosis, Severe; Anxiety

Summary: the art-vr trial is an international multi-center, open label, randomized controlled trial evaluating the effect of an immersive vr environment on procedural anxiety in patients undergoing transfemoral aortic valve replacement (tavr) under local anaesthesia.

virtual reality (vr) allows patients to be fully immerged in an engaging, interactive 3d environment. its applications are broad and include treatment of phobias, stress-disorders, pain reduction. recently, vr has been adopted in various medical procedures to reduce pre- and per-procedural anxiety. in tavr, per-procedural vr immersion could potentially reduce patient anxiety leading to increased overall patient satisfaction. however, contemporary large scale, randomized evidence on vr application in tavr is lacking. the objective of this trial is to evaluate the effect of an immersive vr environment on procedural anxiety in patients undergoing tavr under local anaesthesia in a randomized controlled setting. a total of 150 patients with severe aortic stenosis (as) who undergo transfemoral tavr under local aneasthesia will be included. the main study endpoint is procedural anxiety assessed on a visual analogue scale (vas) directly post-procedure.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * symptomatic severe aortic stenosis * indication for transfemoral tavi under local anaesthesia per local heart team consensus * patient is able to understand and sign written informed consent * patient speaks dutch, german or english exclusion criteria: * need for emergent tavi * need for planned concomitant cardiac intervention during index procedure * history of tavi under local anesthesia/conscious sedation * chronic use of benzodiapines, opioids, pregabalin or antidepressants * history of opioid use (within 8-30 days prior to randomization) * claustrophobia * any psychiatric illness diagnosed by a psychiatrist or psychologist * blindness or severe visual impairment despite visual aid (glasses, contact lenses) * epilepsy * extensive cognitive impairment (mmse \<21 or as diagnosed by geriatrician)

Keywords: immersive virtual reality procedural anxiety tavr
computer-assisted hair implantation using artas system vs manual implantation technique hair restoration study

Conditions: Androgenic Alopecia

Summary: to investigate and compare the safety and effectiveness of the artas™ system to manual hair follicle implantation method following a nine month period of post-procedure evaluation.

this comparative study is a multi-center, prospective, blinded, randomized controlled clinical study where subjects act as their own control. the purpose of this study is to demonstrate that the artas system is safe and effective for implanting follicular hair units. patients will be followed for a nine months period of time.

Eligibility criteria:
inclusion criteria: * subject is male with clinical diagnosis of androgenetic alopecia with norwood-hamilton grade of iv-vi; * subject is 29 to 70 years old; * subject has black or brown hair color; * subject has straight hair; * subject agrees to cut hair short (about 1-1.4 mm) on the scalp in the designated study areas for harvesting and implantation; * subject agrees to have 6 dot tattoos placed on scalp; * subject is able to understand and provide written consent; and * subject consents to post-operative follow-up per protocol. exclusion criteria: * subject has prior history of scalp reduction surgery(s); * subject has prior history of hair restoration procedure(s) using the strip excision technique; * subject has bleeding diathesis; * subject has active use of anti-coagulation medication; * subject has used finasteride in the previous 6 months, or plans to use finasteride during the study; * subject has used minoxidil in the previous 2 weeks, or plans to use minoxidil during the study; or * subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study.
diaphragmatic paralysis after ultrasound block of the suprascapular nerve for shoulder surgery

Conditions: Surgery

Summary: shoulder surgery is a source of intense postoperative pain that justifies the use of opioids. in this context, analgesia provided by locoregional anesthesia (alr) improves the rehabilitation of patients by reducing the length of hospital stay and morphine consumption. thus anesthesia of the brachial plexus interscalene (interscalene block or bis) is considered as the reference technique for the management of post-operative pain after shoulder surgery. it is however provider of hemi-diaphragmatic paralysis (phd) in nearly 100% of cases. thus, this technique is usually avoided in patients with respiratory insufficiency. in arthroscopic shoulder surgery, the development of a suprascapular and axillary nerve (ssax) conjugate block appears to be an effective analgesic alternative in this context.

two ultrasound-guided approaches of the suprascapular nerve (anterior and posterior approaches) have been described in the literature. from an anatomical point of view, the anterior approach could expose patients to the risk of ipsilateral phd by phrenic nerve block secondary to diffusion of the local anesthetic into the supraclavicular region. by measuring the diaphragm excursion during a sniff test, ultrasound allows reliable and reproducible analysis of the diaphragm function. no study has evaluated the incidence of phd after ultrasound block of the suprascapular nerve. knowing the influence of the approach on this complication could be of major interest in this context.

Eligibility criteria:
inclusion criteria: * to benefit from scheduled arthroscopic surgery of the shoulder under general anesthesia * affiliate or beneficiary of a social security scheme * having signed the informed consent exclusion criteria: * the existence of contralateral diaphragmatic paralysis * pre-existing respiratory insufficiency * impossibility of performing diaphragmatic ultrasound * the patient's refusal * the existence of major spontaneous or acquired haemostatic disorders * an infection at the point of puncture * allergy to local anesthetics * pregnant or likely to be pregnant * patients under protection of the adults (guardianship, curators or safeguard of justice) * patients whose cognitive state does not allow assessment by the scales used

Keywords: shoulder surgery local regional anesthesia
a phase 1b study of omp-305b83 plus paclitaxel in subjects with ovarian, peritoneal or fallopian tube cancer

Conditions: Cancer Ovaries; Cancer Peritoneal; Cancer, Fallopian Tube

Summary: the purpose of this study is to test the efficacy and safety of an experimental drug, omp-305b83, when given in combination with paclitaxel. omp-305b83 is a humanized monoclonal antibody and was developed to target cancer stem cells. based on preclinical studies, it is believed that omp-305b83 may block the growth of cancer stem cells and may also impair the productive growth of new blood vessels, which tumors need to grow and spread.

this is an open-label, phase 1b dose escalation and expansion study of omp-305b83 plus paclitaxel designed to evaluate the safety, efficacy and pharmacokinetics of omp-305b83 in combination with paclitaxel in patients with platinum resistant ovarian, primary peritoneal or fallopian tube cancer. this study consists of a screening period, a treatment period and a post-treatment follow up period in which patients will be followed for survival for approximately 12 months. patients will be enrolled in two stages: a dose-escalation stage and an expansion phase. approximately 30 patients will be enrolled in this study at approximately 5 study centers in the united states (u.s)..

Eligibility criteria:
inclusion criteria: 1. platinum resistant grade 2 or 3 ovarian, primary peritoneal or fallopian tube cancer 2. measureable disease per response evaluation criteria (recist) v1.1 3. prior bevacizumab 4. age \> or = 21 years 5. adequate organ and marrow function 6. for women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit. 7. ability to understand and the willingness to sign a written informed consent document exclusion criteria: 1. treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy. prior therapy with weekly paclitaxel for recurrent disease, unless administered more than 2 years prior to enrollment, unless part of an upfront treatment strategy. 2. history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, clinical signs or symptoms of gastrointestinai obstruction or other known clinically signification gastrointestinal disease. 3. subjects with brain metastases 4. subjects with leptomeningial disease or neoplasms in the last 5 years 5. blood pressure \>140/80 6. significant intercurrent illness that will limit the patient's ability to participate in the study 7. subjects with known metastases that are currently involving the lumen of the gastrointestinal tract. 8. major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, or anticipation of need for major surgical procedure during the course of the study 9. pregnant or nursing women 10. new york heart association classification ii, iii, or iv 11. inability to comply with study and follow up procedure
astudy to evaluate safety and eficacy of apixaban in japanese acute deep vein thrombosis (dvt) and pulmonary embolism (pe) patients

Conditions: Deep Vein Thrombosis; Pulmonary Embolism

Summary: the purpose of this study is to investigate safety of apixaban in japanese acute dvt/pe subjects when symptomatic dvt/pe subjects are treated with 10 mg bid apixaban for 7 days as initial therapy followed by 5 mg bid apixaban for 23 weeks as long-term therapy (total treatment period is 24 weeks)


Eligibility criteria:
inclusion criteria: * acute symptomatic proximal dvt with evidence of proximal thrombosis * acute symptomatic pe with evidence of thrombosis in segmental or more proximal branches exclusion criteria: * active bleeding or high risk for bleeding contraindicating treatment with ufh and a vka. * uncontrolled hypertension: systolic blood pressure \> 180 mm hg or diastolic blood pressure \> 110 mm hg * subjects requiring dual anti-platelet therapy

Keywords: dvt pe vte
mechanical thrombectomy with the flowtriever device in acute pulmonary embolism - a retrospective analysis

Conditions: Pulmonary Embolism

Summary: international guidelines recommend intravenous thrombolysis (ivt) for high-risk pulmonary embolism (pe). in high-risk pe where ivt is contraindicated or has failed, surgical embolectomy or catheter-directed intervention (cdi) is recommended. cdi is also recommended as an alternative in patients with intermediate-risk pe with haemodynamic deterioration during anticoagulation treatment. although there is a lack of randomized studies comparing cdi to anticoagulation or systemic thrombolysis in pe, several studies and recent meta-analyses have shown that cdi is an effective treatment that is associated with fewer complications than ivt, especially bleeding.

the flowtriever® retrieval/aspiration system is the first mechanical thrombectomy device to receive pe as an indication from the united states food and drug administration agency. it combines large-bore aspiration with expanding mesh disks designed to trap and subsequently retract the blood clots from the pulmonary arteries. while inari medical, the medical device company that produces the flowtriever® system, has initiated and published a few prospective trials on flowtriever® in pe, non-industry sponsored studies are small and mostly retrospective. in 2021 flowtriever® became the primary device for cdi in pe at sahlgrenska university hospital in gothenburg, sweden. concurrently, several hospitals in sweden have started using flowtriever® in high-risk pe. as such, the method needs evaluation and validation on a local and national level. this retrospective observational study aims to evaluate the outcomes of patients with acute pe treated with the flowtriever® device in sweden. a control group consisting of pe patients treated with ivt will be used for comparison.

Eligibility criteria:
inclusion criteria: * age ≥18 years * acute pe verified by computed tomography (ct) or angiography * pe treated with thrombolysis or flowtriever® during the time period from january 1st of the year when flowtriever was introduced at each respective participating center to the end of 2023. exclusion criteria: * none

Keywords: flowtriever catheter-directed intervention aspirational thrombectomy
registry of pancreatic disease

Conditions: Pancreatic Diseases; Pancreatic Neoplasms; Pancreatitis

Summary: this clinical data registry records information about the health status and healthcare performances received by participants affected by every type of pancreatic disease or disorder. all data (demographic, clinical, biochemical, radiological, pharmacological, genetic...) and audio and/or video recording from operative room are collected in order to be used for prospective or retrospective studies.


Eligibility criteria:
inclusion criteria: * any type of pancreatic disease: inflammatory and neoplastic (including solid and cystic lesions) exclusion criteria: * physically or mentally inability to provide consent